This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.

Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months.

Pelvic irradiation.

Urinary tract infection more than once in the past 12 months.

Acute or chronic prostatitis in the past 12 months.

Clinically significant renal or hepatic impairment.

Bleeding disorder.

Poorly controlled diabetes type 1 or type 2.

Urinary retention in the previous 12 months.

Self-catheterization for urinary retention.

Post-void residual urine volume > 200 mL.

Prior significant rectal surgery or any rectal condition with rectal stenosis or fistula.

History of alcohol or substance abuse or dependence within the past 2 years.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620515